Findings describe the efficacy and safety results of clinical trials of fremanezumab through 12 months of treatment in patients with chronic and episodic migraine
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced results from new long-term analyses of the efficacy and safety of fremanezumab, being presented at the 71st Annual Meeting of the American Academy of Neurology (AAN) in Philadelphia from May 4-10, 2019.
The findings, presented across 13 abstracts at this year’s meeting, describe the primary and other key endpoints, as well as pooled and subgroup data from a 52-week, multicenter, randomized, double-blind, parallel group long-term extension study that evaluated fremanezumab in adults with migraine. The results presented include data on the efficacy of fremanezumab observed through 12 months of treatment in patients with migraine, including populations with inadequate responses to multiple classes of preventive medications, quality of life and the safety profile.
“We are pleased to join the neurology community at this year’s AAN meeting and share these long-term data results on fremanezumab as a preventive treatment option for patients living with migraine,” said Danny McBryan, Senior Vice President, Head of Global Medical Affairs and Pharmacovigilance at Teva. “These data, studied in a wide range of migraine patient populations, add to our growing body of evidence about fremanezumab, and further demonstrate our ongoing commitment to improving the lives of those who suffer from migraine.”
The long-term extension study of fremanezumab included patients rolled over from two placebo-controlled studies, as well as 312 newly enrolled patients. Patients were assigned to either monthly dosing (225 mg monthly; chronic migraine: starting dose of 675 mg), or quarterly dosing (675 mg every three months). A total of 1,890 patients were enrolled and 1,494 completed 12 months of treatment. Patients included those with chronic migraine (CM) and episodic migraine (EM).
A selection of key data points of note across the analyses are summarized below.
Long-term efficacy and safety results:
Quarterly dosing persistency results:
Quality of life results:
AJOVY® (fremanezumab-vfrm) injection is indicated for the preventive treatment of migraine in adults.
IMPORTANT SAFETY INFORMATION
Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.
Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.
Adverse Reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.
Please click here for full Prescribing Information for AJOVY® (fremanezumab-vfrm) injection.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 35,000 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com
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1Mcallister P, et al. Long-Term Impact of Fremanezumab on Response Rates, Acute Headache Medication Use, and Disability in Patients With Chronic Migraine: Results of a 1-Year Study. Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.
2Brandes JL, et al. Long-Term Impact of Fremanezumab on Response Rates, Acute Headache Medication Use, and Disability in Patients With Episodic Migraine: Results of a 1-Year Study. Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.
3Lipton R, et al. Long-Term Efficacy of Fremanezumab in Patients Who Reverted From a Chronic to an Episodic Migraine Classification. Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.
4Ning X, et al. Long-Term Safety of Fremanezumab: Results of a 1-Year Study. Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.
5Blaise CA, et al. Quarterly Administration of Fremanezumab Does Not Show “Wearing Off” Effect During Third Month After Injection. Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.
6Cohen J, et al. Long-Term Impact of Fremanezumab on Headache-Related Disability, Quality of Life, and Patient Satisfaction in Episodic Migraine and Chronic Migraine Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.
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